Olympus Recalls ShockPulse-SE Lithotripsy Systems Due to Mis-wired Components
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Olympus Corporation of the Americas has recalled 55 ShockPulse-SE Lithotripsy Systems distributed internationally due to a mis-wired component that may cause treatment delays.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 3, 2026 and geographically references Canada, Germany, Singapore, Australia, India. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the ShockPulse-SE Lithotripsy System with Generator. The recall was prompted by the discovery of a mis-wired component within the system's generator. This defect can result in additional electrical noise on the power supply output, which is inconsistent with electromagnetic compatibility (EMC) standards. This noise may decrease the overall reliability of the system and potentially lead to delays in medical treatment.
Which Products Are Affected
The recall affects 55 units distributed internationally. The affected products include:
- Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator
- Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes
- Model/Catalog Number: SPL-SR (contains generator SPL-G)
- UDI: SPL-SR 00821925043824, SPL-G 00821925044203
- Serial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003.
These units were distributed in Canada, Germany, Singapore, Australia, and India.
What You Should Do
The recalling firm, Olympus Corporation of the Americas, initiated notification to affected parties via letter on January 8, 2026. Healthcare facilities and distributors in the affected regions should identify if they possess any of the listed serial numbers and follow the specific instructions provided in the firm's notification letter regarding the impacted devices.
Why This Matters
The mis-wired component compromises the system's adherence to safety and electromagnetic standards. This failure can lead to equipment instability and unexpected delays during surgical procedures intended to fragment urinary tract stones, potentially impacting patient care.
Source
Original source: FDA Official Notice ↗
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